Diseño del sistema de calidad farmacéutico para la elaboración de medicamentos en la planta piloto de la Universidad de Navarra
- Autores: Lluís Pascual Masiá
- Directores de la Tesis: Fernando Martínez (dir. tes.), Mª Isabel Calvo (dir. tes.)
- Lectura: En la Universidad de Navarra ( España ) en 2024
- Idioma: español
- Tribunal Calificador de la Tesis: Juan Manuel Irache Garreta (presid.), María Concepción Tros de Ilarduya Apaolaza (secret.), Ana Melero Zaera (voc.), Ana Célia Caetano (voc.), Luis Alberto del Río Álvarez (voc.)
- Programa de doctorado: Programa de Doctorado en Medicamentos y Salud por la Universidad de Navarra
- Calificación: Sobresaliente Cum Laude
- Materias:
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- Resumen
The Pharmacy of the Clínica Universidad de Navarra (SF-CUN) provides personalized medical drugs to patients through its semi-industrial compounding facility, the Planta Piloto (PP). The complexity of PP's operations implies addressing potential risks to patient safety. Industrial quality principles were adapted to the PP's capacities, guided by the design of a Pharmaceutical Quality System (PQS) defining strategies to produce medicines with established quality levels. The PQS encompasses five main components: compounding, documents management, premises and equipment, quality control, and warehouse management. The quality policy drives the PP's work towards obtaining high-quality drugs through proper design and continuous improvement. The quality plan outlines actions to achieve the quality policy, fostered by a quality culture and the Shingo model. SMARTER metrics are meant to quantify the quality system's performance across sections. Top management's involvement, resource allocation, and active review of the PQS are key. Open communication is promoted, and the licensed pharmacist reviews all documentation, authorizing drug release or destruction. Change controls mitigate risks and facilitate continuous improvement, while risk assessments inform decision-making. Personnel responsibilities are delineated, with the licensed pharmacist accountable for training and supervision. Competence-based training and knowledge management are emphasized, and employee perspectives are considered. Classified and non-classified spaces adhere to environmental and microbiological standards, with equipment qualification, calibration, and single-use systems prioritized. The hierarchical documentary system includes a quality manual, procedures, and records, with controlled access and good documentation practices. Compounding activities are classified based on drug types, with varying degrees of normalization and validation, depending on the severity and likelihood of the risks they imply. Drug development follows Quality by Design and product management principles, including stability studies. Quality control ensures raw material compliance, equipment qualification, environmental monitoring, and analytical method validation. Non-conformances are investigated, and a sample library is maintained. Outsourcing requires quality agreements and monitoring, while a local pharmacovigilance system manages complaints, quality defects, and product recalls. Self-inspections and Gemba walks assess compliance with quality criteria and identify improvement opportunities, culminating in an annual report. The PQS aims to manage risks while expanding the PP's capabilities, tailored to its resources and daily operations, with principles applicable to other compounding facilities.
